Pneumostoma management system packaging and kits

ABSTRACT

A flexible pneumostoma management device maintains the patency of a pneumostoma while controlling the flow of material through the pneumostoma. The device is provided to patients in a sterile tray. The tray is efficiently packaged in order to supply a patient&#39;s needs for a period of time. Auxiliary and/or diagnostic materials can also be provided as part of the kit.

CLAIM TO PRIORITY

This application claims priority the following applications:

U.S. Provisional Patent Application No. 61/408,852, filed Nov. 1, 2010, entitled “PNEUMOSTOMA MANAGEMENT SYSTEM PACKAGING AND KITS” (Attorney Docket No. LUNG1-06024U50).

The afore-mentioned application is incorporated herein by reference in its entirety.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is related to all of the following applications, and all the patent applications that claim priority thereto, including:

U.S. patent application Ser. No. 12/388,447, filed Feb. 18, 2009, entitled “PNEUMOSTOMA MANAGEMENT SYSTEM AND METHODS FOR TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No. LUNG1-06001US1); and

U.S. patent application Ser. No. 12/388,451, filed Feb. 18, 2009, entitled “PNEUMOSTOMA MANAGEMENT METHOD FOR TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No. LUNG1-06001US2); and

U.S. patent application Ser. No. 12/388,458, filed Feb. 18, 2009, entitled “FLEXIBLE PNEUMOSTOMA MANAGEMENT SYSTEM AND METHODS FOR TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No. LUNG1-06004US1); and

U.S. patent application Ser. No. 12/684,699, filed Jan. 8, 2010, entitled “PNEUMSTOMA MANAGEMENT DEVICE WITH INTEGRATED PATENCY SENSOR AND METHOD” (Attorney Docket No. LUNG1-06016US1); and

U.S. patent application Ser. No. 12/388,466, filed Feb. 18, 2009, entitled “ONE-PIECE PNEUMOSTOMA MANAGEMENT SYSTEM AND METHODS FOR TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No. LUNG1-06017US1); and

U.S. patent application Ser. No. 12/388,467, filed Feb. 18, 2009, entitled “PNEUMOSTOMA MANAGEMENT SYSTEM WITH SECRETION MANAGEMENT FEATURES FOR TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No. LUNG1-06019US1); and

U.S. patent application Ser. No. 12/388,468, filed Feb. 18, 2009, entitled “MULTI-LAYER PNEUMOSTOMA MANAGEMENT SYSTEM AND METHODS FOR TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No. LUNG1-06022US1); and

U.S. patent application Ser. No. 12/388,469, filed Feb. 18, 2009, entitled “VARIABLE LENGTH PNEUMOSTOMA MANAGEMENT SYSTEM FOR TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No. LUNG1-06023US1); and′

U.S. patent application Ser. No. 13/______, filed Aug. ______, 2011, entitled “PNEUMOSTOMA MANAGEMENT SYSTEM PACKAGING AND KITS” (Attorney Docket No. LUNG1-06024US2).

All of the afore-mentioned applications are incorporated herein by reference in their entireties. This patent application also incorporates by reference in their entireties all patents, applications, and articles discussed and/or cited herein.

BACKGROUND OF THE INVENTION

In the United States alone, approximately 14 million people suffer from some form of Chronic Obstructive Pulmonary Disease (COPD). However, an additional ten million adults have evidence of impaired lung function indicating that COPD may be significantly underdiagnosed. The cost of COPD to the nation in 2002 was estimated to be $32.1 billion. Medicare expenses for COPD beneficiaries were nearly 2.5 times that of the expenditures for all other patients. Direct medical services accounted for $18.0 billion, and indirect cost of morbidity and premature mortality was $14.1 billion. COPD is the fourth leading cause of death in the U.S. and is projected to be the third leading cause of death for both males and females by the year 2020.

Chronic Obstructive Pulmonary Disease (COPD) is a progressive disease of the airways that is characterized by a gradual loss of lung function. In the United States, the term COPD includes chronic bronchitis, chronic obstructive bronchitis, and emphysema, or combinations of these conditions. In emphysema the alveoli walls of the lung tissue are progressively weakened and lose their elastic recoil. The breakdown of lung tissue causes progressive loss of elastic recoil and the loss of radial support of the airways which traps residual air in the lung. This increases the work of exhaling and leads to hyperinflation of the lung. When the lungs become hyperinflated, forced expiration cannot reduce the residual volume of the lungs because the force exerted to empty the lungs collapses the small airways and blocks air from being exhaled. As the disease progresses, the inspiratory capacity and air exchange surface area of the lungs is reduced until air exchange becomes seriously impaired and the individual can only take short shallow labored breaths (dyspnea).

The symptoms of COPD can range from the chronic cough and sputum production of chronic bronchitis to the severe disabling shortness of breath of emphysema. In some individuals, chronic cough and sputum production are the first signs that they are at risk for developing the airflow obstruction and shortness of breath characteristic of COPD. With continued exposure to cigarettes or noxious particles, the disease progresses and individuals with COPD increasingly lose their ability to breathe. Acute infections or certain weather conditions may temporarily worsen symptoms (exacerbations), occasionally where hospitalization may be required. In others, shortness of breath may be the first indication of the disease. The diagnosis of COPD is confirmed by the presence of airway obstruction on testing with spirometry. Ultimately, severe emphysema may lead to severe dyspnea, severe limitation of daily activities, illness and death.

There is no cure for COPD or pulmonary emphysema, only various treatments, for ameliorating the symptoms. The goal of current treatments is to help people live with the disease more comfortably and to prevent the progression of the disease. The current options include: self-care (e.g., quitting smoking), medications (such as bronchodilators which do not address emphysema physiology), long-term oxygen therapy, and surgery (lung transplantation and lung volume reduction surgery). Lung Volume Reduction Surgery (LVRS) is an invasive procedure primarily for patients who have a localized (heterogeneous) version of emphysema; in which, the most diseased area of the lung is surgically removed to allow the remaining tissue to work more efficiently. Patients with diffuse emphysema cannot be treated with LVRS, and typically only have lung transplantation as an end-stage option. However, many patients are not candidates for such a taxing procedure.

A number of less-invasive surgical methods have been proposed for ameliorating the symptoms of COPD. In one approach new windows are opened inside the lung to allow air to more easily escape from the diseased tissue into the natural airways. These windows are kept open with permanently implanted stents. Other approaches attempt to seal off and shrink portions of the hyperinflated lung using chemical treatments and/or implantable plugs. However, these proposals remain significantly invasive and are still unproven. None of the surgical approaches to treatment of COPD has been widely adopted. Therefore, a large unmet need remains for a medical procedure that can sufficiently alleviate the debilitating effects of COPD and emphysema.

SUMMARY OF THE INVENTION

In view of the disadvantages of the state of the art, Applicants have developed a method for treating COPD in which an artificial passageway is made through the chest wall into the lung. An anastomosis is formed between the artificial passageway and the lung by creating a pleurodesis between the visceral and parietal membranes surrounding the passageway as it enters the lung. The pleurodesis prevents air from entering the pleural cavity and causing a pneumothorax (deflation of the lung due to air pressure in the pleural cavity). The pleurodesis is stabilized by a fibrotic healing response between the membranes. The artificial passageway through the chest wall also becomes epithelialized. The result is a stable artificial aperture through the chest wall which communicates with the parenchymal tissue of the lung.

The aperture into the lung through the chest wall is referred to herein as a pneumostoma. A pneumostoma provides an extra pathway that allows air to exit the lung while bypassing the natural airways which have been impaired by COPD and emphysema. By providing this ventilation bypass, the pneumostoma allows the stale air trapped in the lung to escape from the lung thereby shrinking the lung (reducing hyperinflation). By shrinking the lung, the ventilation bypass reduces breathing effort (reducing dyspnea), allows more fresh air to be drawn in through the natural airways and increases the effectiveness of all of the tissues of the lung for gas exchange. Increasing the effectiveness of gas exchange allows for increased absorption of oxygen into the bloodstream and also increased removal of carbon dioxide. Reducing the amount of carbon dioxide retained in the lung reduces hypercapnia which also reduces dyspnea. The pneumostoma thereby achieves the advantages of lung volume reduction surgery without surgically removing a portion of the lung or sealing off a portion of the lung.

Procedures, techniques and tools for creating a pneumostoma are described in Applicants' copending patent application No. 12/388,453 entitled “Surgical Instruments For Creating A Pneumostoma And Treating Chronic Obstructive Pulmonary Disease” to Tanaka et al. Pneumostoma management devices which can be inserted into a pneumostoma and through which gases may exit a lung of a patient are described in Applicant's copending patent application No. 12/388,468 entitled “Multi-Layer Pneumostoma Management System And Methods For Treatment Of Chronic Obstructive Pulmonary Disease” to Tanaka et al. These patent applications, and all other patents and patent applications referred to herein, are incorporated by reference in their entirety.

Pneumostoma management devices and auxiliary supplies are supplied to patients on a regular basis for maintaining the pneumostoma. In some cases, pneumostoma management devices are single use disposable items which are replaced daily. It is therefore desirable to provide the pneumostoma management devices to suppliers and patients in a volume efficient manner.

In accordance with one embodiment, the present invention provides sterile trays for delivery of pneumostoma management devices.

In accordance with another embodiment, the present invention provides a pneumostoma management device in a sterile tray.

In accordance with another embodiment, the present invention provides volume-efficient packaging. The packaging is configured for delivery of a plurality of pneumostoma management devices.

In accordance with one embodiment, the present invention provides kits having a plurality of pneumostoma management devices secured in volume-efficient packaging for delivery to a patient.

In accordance with one embodiment, the present invention provides kits having a plurality of pneumostoma management devices secured in volume-efficient packaging and also includes one or more auxiliary supplies used by a patient during exchange of pneumostoma management devices.

In accordance with one embodiment, the present invention provides kits having a plurality of pneumostoma management devices secured in volume-efficient packaging and also includes one or more enhanced-functionality pneumostoma management devices.

In accordance with one embodiment, the present invention provides kits having a plurality of pneumostoma management devices secured in volume-efficient packaging for delivery to a patient and also includes features to guide the patient in periodic maintenance and or assessment of the pneumostoma

In accordance with one embodiment, the present invention provides kits having a plurality of pneumostoma management devices secured in volume-efficient packaging for delivery to a patient. The volume-efficient packaging is also useful for controlled disposal of pneumostoma management devices.

Thus, various systems, components and methods are provided for delivery of pneumostoma management devices and managing a pneumostoma and thereby treating COPD. Other objects, features and advantages of the invention will be apparent from drawings and detailed description to follow.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and further features, advantages and benefits of the present invention will be apparent upon consideration of the present description taken in conjunction with the accompanying drawings.

FIG. 1A shows the chest of a patient indicating alternative locations for a pneumostoma that may be managed using the device and methods of the present invention.

FIG. 1B shows a sectional view of the chest illustrating the relationship between the pneumostoma, lung and natural airways.

FIG. 1C shows a detailed sectional view of a pneumostoma.

FIG. 2A shows an exploded view of components of a pneumostoma management device.

FIG. 2B shows an assembled pneumostoma management device according to an embodiment of the present invention.

FIG. 2C shows a perspective view of a component of the pneumostoma management device of FIGS. 2A-2B.

FIG. 2D shows a perspective view of the assembled pneumostoma management device of FIGS. 2A-2B.

FIG. 2E shows a sectional view of the pneumostoma management device of FIGS. 2A, 2B, 2D inserted into a pneumostoma.

FIG. 3A shows components of covers for the adhesive portions of the pneumostoma management device of FIGS. 2A-2D.

FIG. 3B shows a component of the covers of FIG. 3A.

FIG. 3C shows a partially-covered pneumostoma management device.

FIG. 3D shows a partially-covered pneumostoma management device.

FIG. 3E shows a fully-covered pneumostoma management device according to an embodiment of the present invention.

FIG. 3F shows a perspective view of an alternate fully-covered pneumostoma management device according to an embodiment of the present invention.

FIG. 4A shows an exploded view of a tray for a pneumostoma management device according to an embodiment of the present invention.

FIG. 4B shows a perspective view of the tray of FIG. 4A, assembled with a pneumostoma management device.

FIG. 5A shows a perspective view of a strip of trays for pneumostoma management devices according to an embodiment of the present invention.

FIG. 5B shows a perspective view of an assembly of four strips of the trays of FIG. 5B.

FIG. 5C shows the assembly of FIG. 5B with external packaging according to an embodiment of the present invention.

FIG. 6A shows a plan view of a support for holding multiple trays according to an embodiment of the present invention.

FIG. 6B shows a perspective view of the support of FIG. 6A as assembled.

FIG. 6C shows a perspective view of the support of FIGS. 6A and 6B as assembled with multiple trays.

FIG. 7 shows a perspective view of an alternative support for holding multiple trays according to an embodiment of the present invention.

FIG. 8A shows a perspective view of an alternative single tray support according to an embodiment of the present invention.

FIG. 8B shows packaging for multiple trays utilizing the alternative single tray support of FIG. 8A.

DETAILED DESCRIPTION OF THE INVENTION

The following description is of the best modes presently contemplated for practicing various embodiments of the present invention. The description is not to be taken in a limiting sense, but is made merely for the purpose of describing the general principles of the invention. It is to be understood that features described in reference to a particular embodiments may be combined with features of other particular embodiments. The scope of the invention should be ascertained with reference to the claims. In the description of the invention that follows, like numerals or reference designators will be used to refer to like parts or elements throughout. In addition, the first digit of a reference number identifies the series of drawings in which the reference number first appears.

Pneumostoma Formation and Anatomy

FIG. 1A shows the chest of a patient indicating alternative locations for creating a pneumostoma that may be managed using the system and methods of the present invention. A first pneumostoma 110 is shown on the front of the chest 100 over the right lung 101 (shown in dashed lines). The pneumostoma is preferably positioned over the third intercostal space on the mid-clavicular line. Thus the pneumostoma 110 is located on the front of the chest between the third and fourth ribs. Although the pneumostoma 110 is preferably located between two ribs, in alternative procedures a pneumostoma can also be prepared using a minithoracotomy with a rib resection.

In FIG. 1A, a second pneumostoma 112 is illustrated in a lateral position entering the left lung 103 (shown in dashed lines). The pneumostoma 112 is preferably positioned over the fourth or fifth intercostal space under the left arm 104. In general, one pneumostoma per lung is created; however, more or less than one pneumostoma per lung may be created depending upon the needs of the patient. In most humans, the lobes of the lung are not completely separate and air may pass between the lobes.

A pneumostoma is surgically created by forming an artificial channel through the chest wall and joining that channel with an opening through the visceral membrane of the lung into parenchymal tissue of the lung to form an anastomosis. The anastomosis is joined and sealed by sealing the channel from the pleural cavity using adhesives, mechanical sealing and/or pleurodesis. Methods for forming the channel, opening, anastomosis and pleurodesis are disclosed in Applicant's pending and issued patents and applications including U.S. patent application Ser. No. 10/881,408 entitled “Methods and Devices to Accelerate Wound Healing in Thoracic Anastomosis Applications” and U.S. patent application Ser. No. 12/030,006 entitled “Variable Parietal//Visceral Pleural Coupling” which are incorporated herein by reference in their entirety.

FIG. 1B shows a sectional view of chest 100 illustrating the position of the pneumostoma 110. The parenchymal tissue 132 of the lung 130 is comprised principally of alveoli 134. The alveoli 134 are the thin walled air-filled sacs in which gas exchange takes place. Air flows into the lungs through the natural airways including the trachea 136, carina 137, and bronchi 138. Inside the lungs, the bronchi branch into a multiplicity of smaller vessels referred to as bronchioles (not shown). Typically, there are more than one million bronchioles in each lung. Each bronchiole connects a cluster of alveoli to the natural airways. As illustrated in FIG. 1B, pneumostoma 110 comprises a channel through the thoracic wall 106 of the chest 100 between two ribs 107. Pneumostoma 110 opens at an aperture 126 through the skin 114 of chest 100.

FIG. 1C shows a detailed sectional view of the pneumostoma 110. As illustrated in FIG. 1C, pneumostoma 110 comprises a channel 120 through the thoracic wall 106 of the chest 100 between the ribs 107. The channel 120 is joined to cavity 122 in the parenchymal tissue 132 of lung 130. Although shown having a particular shape, the channel 120 and cavity 122 will typically conform to the shape of a device inserted into the pneumostoma 110. An adhesion or pleurodesis 124 surrounds the channel 120 where it enters the lung 130. The thoracic wall 106 is lined with the parietal membrane 108. The surface of the lung 130 is covered with a continuous sac called the visceral membrane 138. The parietal membrane 108 and visceral membrane 138 are often referred to collectively as the pleural membranes. Between the parietal membrane 108 and visceral membrane 138 is the pleural cavity (pleural space) 140. The pleural cavity usually only contains a thin film of fluid that serves as a lubricant between the lungs and the chest wall. In pleurodesis 124 the pleural membranes are fused and/or adhered to one another eliminating the space between the pleural membranes in that region.

An important feature of the pneumostoma is the seal or adhesion surrounding the channel 120 where it enters the lung 130 which may comprise a pleurodesis 124. A pleurodesis 124 is the fusion or adhesion of the parietal membrane 108 and visceral membrane 138. A pleurodesis may be a complete pleurodesis in which the entire pleural cavity 140 is removed by fusion of the visceral membrane 138 with the parietal membrane 108 over the entire surface of the lung 130. However, as shown in FIG. 1C, the pleurodesis is preferably localized to the region surrounding the channel 120. The pleurodesis 124 surrounding the channel 120 prevents air from entering the pleural cavity 140. If air is permitted to enter pleural cavity 140, a pneumothorax will result and the lung may collapse.

Pleurodesis 124 can be created between the visceral pleura of the lung and the inner wall of the thoracic cavity using chemical methods including introducing into the pleural space irritants such as antibiotics (e.g. Doxycycline or Quinacrine), antibiotics (e.g. iodopovidone or silver nitrate), anticancer drugs (e.g. Bleomycin, Mitoxantrone or Cisplatin), cytokines (e.g. interferon alpha-2β and Transforming growth factor-β); pyrogens (e.g. Corynebacterium parvum, Staphylococcus aureus superantigen or OK432); connective tissue proteins (e.g. fibrin or collagen) and minerals (e.g. talc slurry). A pleurodesis can also be created using surgical methods including pleurectomy. For example, the pleural space may be mechanically abraded during thoracoscopy or thoracotomy. This procedure is called dry abrasion pleurodesis. A pleurodesis may also be created using radiotherapy methods, including radioactive gold or external radiation. These methods cause an inflammatory response and or fibrosis, healing, and fusion of the pleural membranes. Alternatively, a seal can be created in an acute manner between the pleural membranes using biocompatible glues, meshes or mechanical means such as clamps, staples, clips and/or sutures. The adhesive or mechanical seal may develop into pleurodesis over time. A range of biocompatible glues are available that may be used on the lung, including light-activatable glues, fibrin glues, cyanoacrylates and two part polymerizing glues. Applicant's copending U.S. patent application Ser. No. 12/030,006 entitled “VARIABLE PARIETAL/VISCERAL PLEURAL COUPLING” discloses methods such as pleurodesis for coupling a channel through the chest wall to the inner volume of the lung without causing a pneumothorax and is incorporated herein by reference for all purposes.

When formed, pneumostoma 110 provides an extra pathway for exhaled air to exit the lung 130 reducing residual volume and intra-thoracic pressure without the air passing through the major natural airways such as the bronchi 138 and trachea 136. Collateral ventilation is particularly prevalent in an emphysemous lung because of the deterioration of lung tissue caused by COPD. Collateral ventilation is the term given to leakage of air through the connective tissue between the alveoli 134. Collateral ventilation may include leakage of air through pathways that include the interalveolar pores of Kohn, bronchiole-alveolar communications of Lambert, and interbronchiolar pathways of Martin. This air typically becomes trapped in the lung and contributes to hyperinflation. In lungs that have been damaged by COPD and emphysema, the resistance to flow in collateral channels (not shown) of the parenchymal tissue 132 is reduced allowing collateral ventilation to increase. Air from alveoli 134 of parenchymal tissue 132 that passes into collateral pathways of lung 130 is collected in cavity 122 of pneumostoma 110. Pneumostoma 110 thus makes use of collateral ventilation to collect air in cavity 122 and vent the air outside the body via channel 120 reducing residual volume and intra-thoracic pressure and bypassing the natural airways which have been impaired by COPD and emphysema.

By providing this ventilation bypass, the pneumostoma allows stale air trapped in the parenchymal tissue 132 to escape from the lung 130. This reduces the residual volume and intra-thoracic pressure. The lower intra-thoracic pressure reduces the dynamic collapse of airways during exhalation. By allowing the airways to remain patent during exhalation, labored breathing (dyspnea) and residual volume (hyperinflation) are both reduced. Pneumostoma 110 not only provides an extra pathway that allows air to exit the lung 130 but also allows more fresh air to be drawn in through the natural airways. This increases the effectiveness of all of the tissues of the lung 130 and improves gas exchange. Increasing the effectiveness of gas exchange allows for increased absorption of oxygen into the bloodstream and also increased removal of carbon dioxide. Reducing the amount of carbon dioxide retained in the lung reduces hypercapnia which also reduces dyspnea. Pneumostoma 110 thus achieves many of the advantages sought by lung volume reduction surgery without surgically removing a portion of the lung or sealing off a portion of the lung.

Applicants have found that pneumostoma management devices in accordance with embodiments of the present invention are desirable to maintain the patency of the pneumostoma and control flow of materials between the exterior of the patient and the parenchymal tissue of the lung via the pneumostoma. The pneumostoma management devices include a pneumostoma vent to enter the pneumostoma and allow gases to exit the lung and may also include a chest mount, and/or one or more of the tools, packaging, auxiliary device and methods described herein. In general terms a pneumostoma management device (“PMD”) or pneumostoma vent comprises a tube which is inserted into the pneumostoma and an external component which is secured to the skin of the patient to keep the tube in place. Gasses escape from the lung through the tube and are vented external to the patient. The pneumostoma management device may, in some, but not all cases, include a filter which only permits gases to enter or exit the tube. The pneumostoma management device may, in some, but not all cases, include a one-way valve which allows gases to exit the lung but not enter the lung through the tube.

Pneumostoma Vent System

FIGS. 2A-2D show views of a pneumostoma management device 200. Pneumostoma management device 200. FIG. 2A shows an exploded view of the four main components of pneumostoma management device 200. FIG. 2B shows a view of an assembled pneumostoma management device 200. FIG. 2C shows a perspective view of a component of the pneumostoma management device 200. FIG. 2D shows a perspective view of the assembled pneumostoma management device 200. FIG. 2E shows a sectional view of the pneumostoma management device 200 positioned in a pneumostoma.

FIG. 2A shows an exploded view of the four main components of pneumostoma management device. From right to left these components are annular adhesive cover 202, filter 204, pneumostoma vent 206 and hydrocolloid patch 208. Adhesive cover 202 is a thin porous biocompatible membrane which is adhesive on the surface facing the pneumostoma (the inner surface see 222 in FIG. 2C) and non-adhesive on the outer surface 220. A suitable material for adhesive cover 202 is a CHG Chlorhexidine Gluconate IV Securement Dressing available under the Tradename TEGADERM™ from 3M of St. Paul, Minn.. TEGADERM™ is thin layer of polyurethane bonded to a thin hydrocolloid adhesive layer. The film is biocompatible as well as thin, strong, and breathable. Other thin biocompatible dressings and adhesive films may be used as an alternative to TEGADERM™. For example, a suitable material for adhesive cover 202 is a thin polyurethane film bearing an acrylic adhesive—such materials are available from 3M of St. Paul, Minn. The film is biocompatible as well as thin, strong, and breathable. Adhesive cover 202 has an aperture 224 large enough to allow air to exit through filter 204. Aperture 224 may however be slightly smaller than filter 204 so that the cover can be used to secure filter 204 to pneumostoma vent 206. Exposed portions of adhesive cover 202 are provided with a paper cover to protect the adhesive ring prior to use (see FIGS. 3A-3 f).

As shown in FIG. 2A, a filter 204 is positioned between adhesive cover 202 and pneumostoma vent 206. Filter 204 is a circular disc of filter material. Filter 204 is preferably a hydrophobic filter material, for example GORETEX®. Filter 204 is in some embodiments made from reticulated open cell polyurethane foam or an open cell polyurethane or polyester foam or melt blown polyethylene. Exemplary filter materials include DELPORE® DP2001-10P, DELPORE® DP2001-20P, and DELPORE® DP2001-30P available from Delstar Technologies, Inc. (Middletown, Del.). Filter 204 is larger than the proximal aperture in pneumostoma vent 206 and is positioned over the proximal aperture. Filter 204 may be secured to pneumostoma vent 206 by and adhesive, welding, or other bonding technology. In a preferred embodiment, filter 204 is secured to vent flange 262 with a ring of pressure sensitive adhesive. Filter 204 may also be secured to pneumostoma vent 206 by annular adhesive cover 202 instead of or in addition to other bonding techniques. Filter 204 allows gasses to exit the lung through pneumostoma vent 206 while preventing the entry of water and/or contaminants into the lung through the pneumostoma vent. Additionally, filter 204 traps within the pneumostoma vent 206 any liquid or solid discharge from the lung.

As shown in FIGS. 2A and 2C, pneumostoma vent 206 comprises a tube 260 for entering the pneumostoma. Tube 260 has an atraumatic tip 265 and one or more apertures 267 in the distal end to allow gases and discharge to enter tube 260 from the pneumostoma. Tube 260 is connected to a flange 262 at the proximal end. Flange 262 may be formed in one piece with tube 260 or formed separately and joined to tube 260 as previously described with respect to other embodiments. The proximal opening 263 of pneumostoma vent 206 is sized so that filter 204 covers proximal opening 263. Vent 206 may be made of a suitable plastic/thermoplastic polymer/thermoplastic elastomer. For example in one preferred embodiment vent 206 is made of Pebax® a block copolymer with suitable mechanical and chemical properties available from Arkema (Colombes, France).

Referring again to FIG. 2A, hydrocolloid patch 208 has an aperture 209 through which tube 260 can be placed but too small to allow passage of flange 262. Hydrocolloid patch 208 is a biocompatible hydrocolloid material which is naturally sticky like an adhesive on both sides. The hydrocolloid material may be provided with a film coating and a transitional adhesive on the side facing flange 262 and cover 202 in order to better secure hydrocolloid patch 208 to the flange and annular cover. Hydrocolloid patch 208 is preferably less than 3 mm thick and is more preferably, approximately 1 mm in thickness. However, the hydrocolloid patch may be thicker if absorbing requirements of the discharge around the tube is high. Additionally a thicker ring of hydrocolloid may provide a forgiving surface to secure pneumostoma management device 200 to a rough or highly contoured skin surface. Hydrocolloid patch 208 is in some embodiments substantially transparent. Exposed portions of hydrocolloid patch 208 are provided with a paper cover (not shown) to protect the exposed areas of the hydrocolloid patch prior to use.

Referring now to FIG. 2B which shows a plan view of an assembly of all four main components including adhesive cover 202, filter 204, pneumostoma vent 206 and hydrocolloid patch 208. Pneumostoma management device 200 may be provided as a kit of separate components or one or more of the components may be preassembled when provided to the patient. As shown in FIG. 2B, tube 260 fits through the middle of hydrocolloid patch 208. Note also that flange 262 is trapped between annular adhesive cover 202 and filter 204/hydrocolloid patch 208. In this embodiment, filter 204 is also secured to pneumostoma vent 206 by adhesive cover 202. Exposed adhesive regions of annular adhesive ring 202 and hydrocolloid patch 208 on the patient side of the pneumostoma management device 200 are provided with protective covers (for example paper covers) to protect the exposed adhesive areas during shipping and prior to use. The completed or partially completed assembly is provided as a sterile product to the patient or caregiver who inserts the tube 260 of pneumostoma vent 206 into a pneumostoma and secures the hydrocolloid patch 208 and adhesive cover to the skin of the chest surrounding the pneumostoma.

Referring now to FIG. 2D which shows a perspective view of assembled pneumostoma management device 200. The outer edges of filter 204 and hydrocolloid patch 208 are shown by dotted lines. As shown in FIG. 2D, adhesive cover 202 secures filter 204 over pneumostoma vent 206. Tube 260 of pneumostoma vent 206 is aligned with filter 204 such that gases can pass through tube 260 and filter 204.

FIG. 2E shows a sectional view of pneumostoma management device 200 in position within a pneumostoma 110. As shown in FIG. 2E, tube 260 is inserted into the pneumostoma 110 and passes through the wall of chest 100 and into the lung 130. Aperture 267 in the distal end of tube 260 is positioned inside the lung 130 so that gases and discharge may enter the tube 260 of the pneumostoma management device 200. Flange 262 of pneumostoma vent 206 is secured to the skin 114 of the patient by hydrocolloid patch 208 and adhesive cover 202. Flange 262 secures the position of tube 260 within pneumostoma 110. Flange 262 secures the position of aperture 263 on the chest of the patient such that gases from the lung may vent through tube 260 and filter 204. Both hydrocolloid patch 208 and adhesive cover 202 contact the skin 114 of the patient to secure the pneumostoma management device 200 to the chest 100 of the patient. In some cases a barrier film may be applied by the patient prior to securing the pneumostoma management device to reduce skin irritation caused by application and removal of the system. An additional ring of absorbent material (not shown), for example, gauze or another absorbent fabric may be positioned around tube 260 between hydrocolloid patch 208 and the skin 114 of the patient for absorbing any discharge from pneumostoma 110 which escapes around tube 260.

Referring again to FIG. 2E, during use, the distal end 265 of pneumostoma vent 206 is placed into the pneumostoma 110 and tube 260 is pushed gently and slowly into the pneumostoma 110. The pneumostoma tube 260 aligns itself with the pneumostoma 110 such that when the hydrocolloid patch 208 and adhesive cover 202 contacts and adheres to the skin 114 of the chest 100, the aperture 224 is perfectly aligned with the pneumostoma 110. Gasses may then escape from the lung into the pneumostoma 110. Gasses in pneumostoma 110 enter tube 260 and pass through filter 204 and vent to atmosphere as shown by arrow 220.

Protective Covers

One aspect of a pneumostoma management system includes protective covers which protect the adhesive portions of the pneumostoma management device prior to use. These protective covers serve the same purpose as the paper covers on an adhesive bandage. However, in preferred embodiments of the present invention, the protective covers are specially designed to facilitate application of the pneumostoma management device. In a preferred embodiment, the protective covers are made from a thin disposable material which can be readily released from the adhesive surfaces. A suitable material is paper waxed on one surface.

FIGS. 3A-3E shows aspects of a set of protective covers 300 suitable for application to pneumostoma management device 200. FIG. 3A shows all of the components of protective cover set 300 which includes inner covers 310 a, 310 b outer covers 320 a 320 b, tab covers 330 a, 330 b Inner covers 310 a, 310 b are designed to protect the exposed adhesive surface of hydrocolloid patch 208. Outer covers 320 a, 320 b are designed to protect the exposed adhesive surface of adhesive cover 202 without obstructing the removal of inner covers 310 a, 310 b. Tab covers 330 a, 330 b are designed to protect the outer edges of adhesive cover 202 so that a patient can more easily handle the adhesive cover 202 after removal of inner covers 210 a, 210 b and outer covers 220 a, 220 b.

FIGS. 3B-3D illustrate an inner cover 310 b. Inner cover 310 a (not shown) is identical to cover 310 b. As shown in FIG. 3B, inner cover 310 b is substantially congruent in shape with hydrocolloid patch 208 Inner cover 310 b has an aperture 312 b, sized to fit the outer diameter of tube 260. Inner cover 310 b also has a full side 314 b and a truncated side 315 b. Prior to use inner cover 310 b is folded along dotted line 316 b. This results in the configuration shown in FIG. 3C in which aperture 312 b forms a half circle and truncated side 315 b is positioned over full side 314 b. As shown in FIG. 3D full sides 314 a, 314 b of inner covers 310 a, 310 b are placed in contact with the exposed adhesive surface of hydrocolloid patch 208 (obscured). Truncated sides 315 a, 315 b are slightly elevated on either side of pneumostoma vent 260 providing a handle for easy removal of inner covers 310 a, 310 b. During application, inner covers 310 a, 310 b are removed first. Inner covers 310 a, 310 b are removed by gripping and pulling truncated sides 315 a, 315 b to expose hydrocolloid patch 208 (obscured). When hydrocolloid patch 208 is exposed tube 260 is inserted into the pneumostoma and hydrocolloid patch 208 adheres to the skin of the chest. The presence of outer covers 320 a, 320 b and tab covers 330 a, 330 b during insertion of the tube allows the patient to manipulate the tube without touching the tube. Thus the sterility of the tube can be preserved when entering the pneumostoma.

FIG. 3D illustrates the application of tab covers 330 a, 330 b to the outer edges of adhesive cover 202. As shown in FIG. 3D, tab covers 330 a, 330 b protect the outer edges of adhesive cover 202 so that a patient can more easily handle the adhesive cover 202 after removal of inner covers 210 a, 210 b (not shown) and outer covers 220 a, 220 b (not shown). Outer covers 220 a, 220 b are removed subsequent to removal of adhesion of hydrocolloid patch 208 to the skin of the patient. Tab covers 330 a, 330 b allow the patient to handle the outer edges of adhesive cover 202 while the patient pushes the remainder of adhesive cover 202 into contact with skin of the chest. After the major portion of adhesive cover 202 has been secured to the chest, tab covers 330 a, 330 b are removed. In alternative embodiments, tab covers are permanently affixed to the outer edges of adhesive cover 202 in order to facilitate both placement and removal of pneumostoma management device 200.

FIG. 3E shows set of protective covers 300 as assembled with pneumostoma management device 200 (partially obscured). As shown in FIG. 3E, outer covers 320 a, 320 b include inner channels 322 a, 322 b designed to accommodate the removal of inner covers 310 a, 310 b. Pneumostoma vent 206 protrudes from pneumostoma management device 200 through the set of protective covers 300.

FIG. 3F shows an alternative embodiment of a set of protective covers 300 f protective which includes, a tube cover 340 in addition to inner covers 310 a, 310 b outer covers 320 a 320 b, tab covers 330 a, 330 b. As shown in FIG. 3F, tube cover 340 comprises a long rectangular strip 342 of material (for example paper). The strip 342 is folded in half and sides 343, 344 adhered to themselves along part of their length to form a pocket 341, ends 345, 346 can be folder back or adhered to inner covers 310 a, 310 b so that tube cover 340 can be removed at the same time as inner covers 310 a, 310 b. In alternative embodiments a tube cover 340 is made in a different configuration or material than show. In some embodiments, the use of a tube cover in combination with covers for protecting the exposed adhesive portion of the pneumostoma vent is sufficient to preserve the sterility of the pneumostoma management device.

After creating and healing of the pneumostoma the patient will be responsible for applying and removing the pneumostoma management device 200. The patient will typically exchange one pneumostoma management device 200 for another and dispose of the used pneumostoma management device 200. Pneumostoma management device 200 will be replaced periodically, such as daily, or when necessary. The patient will be provided with a supply of pneumostoma management devices 200 by a medical practitioner or by prescription. The pneumostoma management devices are preferably provide to the patient in the form of a pneumostoma management system which includes packaging, instructions and/or auxiliary supplies to facilitate delivery, sterility, disposal and/or proper use of the pneumostoma management device 200.

Pneumostoma Management Systems

In preferred embodiments of the present invention a pneumostoma management system includes one or more pneumostoma management devices and also one or more of sterile packaging, kit packaging, auxiliary supplies and instructions for use. In preferred embodiments the pneumostoma management system, includes packaging and instructions which assist the patient in utilizing the components of the system in the correct sequence. The packaging may include printed instructions which assist the patient in the appropriate sequence of the steps for using the pneumostoma management device. In addition, the packaging can include auxiliary supplies, for example, cleaning and moisturizing swabs and barrier spray/cream. The packaging of the pneumostoma management system may also be designed to provide the components to the patient in the order required for use and to maintain sterility during use. For example, the package may be designed so that, upon opening the package, items are physically arranged in a tray in the order in which they are to be used by the patient.

In preferred embodiments, the packaging is designed to provide pneumostoma management devices and auxiliary materials sufficient to maintain a pneumostoma for multiple days in a volume-efficient package. For example, in preferred embodiments, the packaging is designed to provide pneumostoma management devices and auxiliary materials sufficient to maintain a pneumostoma for one week, two weeks, four weeks or one month.

Sterile Tray

As described above, a pneumostoma management system incorporates in some embodiments a sterile tray which holds the pneumostoma management device prior to use. FIGS. 4A-4B show exploded and assembled views of a pneumostoma management system 400 including a pneumostoma management device 200, a set of protective covers 300, a sterile tray 410 and sterile tray cover 430.

As shown in FIG. 4A, pneumostoma management system 400 includes a tray 410. In a preferred embodiment tray 410 is a vacuum-formed or injection-molded thermoplastic tray. Tray 410 includes a tray base 415 with a planar raised edge 412 and a shallow depression 414, and a tubular extension 416 extending in this preferred embodiment about perpendicular to the tray base 415. Shallow depression 414 is sized to receive the exterior portions of pneumostoma management device 200 and cover 300. For example, shallow depression 414 is in some embodiments approximately 110 mm by 100 mm by 5 mm deep. Tubular extension 416 extends from the middle of shallow depression 414 and is sized to receive the tube 260 of pneumostoma management device 200.

Tray cover 430 is a thin flexible covering which protects the pneumostoma management device and keeps bacteria out of tray 410. Tray cover 430 is adapted to be removably secured top tray 410. Tray cover 430 can be provided with one or more tabs 432 which can be gripped to peel tray cover 430 away from tray 410. The tray cover material is in some embodiments, selected to allow sterilization of the pneumostoma management device 200 inside pneumostoma management system 400 after attachment of cover 430. For example, tray cover is, in some embodiments, selected to be permeable to ethylene oxide such that pneumostoma management system 400 can be sterilized after assembly. In some embodiments tray cover 430 is made of TYVEK® available from DuPont.

During assembly, tube 260 of pneumostoma management device 200 is inserted into tubular extension 416. The external portion of pneumostoma management device 200 is placed in shallow depression 414, and tray cover 430 is secured to raised rim 412. In a preferred embodiment a pressure sensitive and/or contact adhesive is used to secure tray cover 430 to raised rim 412. After assembly pneumostoma management system 400 is exposed to ethylene oxide gas for a preselected period of time. The ethylene oxide penetrates through tray cover 430 and sterilizes the surfaces of tray 410 and also sterilizes the pneumostoma management device 200 and set of covers 300. Thus, the pneumostoma management system provides the pneumostoma management device 200 sterile and ready for use by the patient.

To simplify manufacturing, a single tray configuration is designed to contain a range of different pneumostoma management devices. For example, tubular extension 416 is, in some embodiments, approximately 95 mm deep and 10 mm in inside diameter. Thus, for example, although pneumostoma management devices are made in various sizes having tubes 260 of sizes between 35 mm and 95 mm, a single tray having a tubular extension 95 mm deep can accommodate any of the range of pneumostoma management devices.

FIG. 4B shows a view of pneumostoma management system 400 after assembly and sterilization. Tray cover 430 is secured to tray 410 to protect the pneumostoma management device within tray 410 and maintain sterility during transit. An informational label 440 is adhered and/or printed on tray cover 430. The informational label includes printed information 442 such as size, source origin, batch number and/or other FDA mandated information to identify the pneumostoma management device contained within. The printed label 440 can also include instructions for use. The printed information 442 can be provided alphanumerically and/or with pictograms/symbols.

The tray configuration of FIGS. 4A and 4B is well-suited to protect and maintain the sterility of a pneumostoma management device. However, the tray configuration is not readily packed in a compact size. For example, taking the maximum size of each direction, the single tray configuration occupies a ‘cube’ of 110 mm×100 mm×100 mm. The packaging volume of this ‘cube’ is greater than a liter. In preferred embodiments, where a patient exchanges the pneumostoma management device daily, a month's supply of pneumostoma management devices could occupy a total packaging volume of some 30 liters. This is inconvenient for the patient to carry and store. The difficulty is magnified at the distributor/pharmacy level where pneumostoma management devices must be maintained in multiple sizes for different patients. It would also increase shipping/delivery charges associated with the device. Thus, it is preferred to reduce the effective packaging volume utilizing volume-efficient packaging for multiple trays as described below.

Multi-Tray Strips

To facilitate delivery, pneumostoma management system 400 is, in some embodiments, provided as a part of a multi-tray strip. For example, a multi-tray strip can include two, three, four or more pneumostoma management devices in sterile trays which are releasably or permanently attached to one another. In a preferred embodiment a multi-tray strip can include seven pneumostoma management devices in sterile trays. Each tray preferably is provided with an independent tray cover such that one pneumostoma management device can be removed at a time while preserving the sterility of the remaining pneumostoma management devices.

The trays are, in some embodiments, identical but in other embodiments, include different items. For example, one or more of the pneumostoma management devices can include different components and/or attributes suitable for treating or assessing the pneumostoma on a periodic basis. In some embodiments, for example, one pneumostoma management devices per strip of seven includes means for assessing pneumostoma. Thus, a patient will perform a weekly assessment of pneumostoma health and/or functionality, the results of which the patient can report to a physician in order that the physician can make recommendations regarding further diagnosis and/or treatment of the pneumostoma.

FIG. 5A shows an example of a multi-day strip 510 including seven pneumostoma management systems 400 having interconnected trays 410. The trays 410 are, in some embodiments, formed in one piece. For example the multi-day strip 510 can be vacuum formed in one piece. The tray can be perforated along a line between adjoining trays to allow separation of adjoining trays. Alternatively, the trays 410 are releasably attached to one another before or after sterilization. For example, adjoining trays can be secured to one another using a releasable tape. Note however, that each tray 410 has a tray cover 430 that can be removed independently of the remaining tray covers 430.

FIG. 5B shows a suitable configuration for packaging together including four multi-day strips 510. As shown in FIG. 5B, the four pneumostoma multi-day strips 510 are arranged in the shape of a rectangular cuboid with the tubular extensions 416 of the trays arranged in the inner volume of the rectangular cuboid. Each of the four multi-day strips is linearly displaced from neighboring strips by at least the width of the tubular extensions 416 so that tubular extensions 416 do not interfere with one another.

FIG. 5C shows a kit 500 which includes four multi-day strips 510 arranged in the configuration of FIG. 5B and packaged in external packaging 520. External packaging 520 is a medical-grade card box. In this configuration, 28 pneumostoma management systems 400 can be supplied in a total package volume of approximately 8 liters or 0.29 liters per unit. This is a considerable savings in packaging volume compared to individual packaging. Kit 500 is a manageable size for delivery to a patient and transportation by a patient and supplies a patient with the ability to maintain a pneumostoma for four weeks without returning to the pharmacy.

External packaging 520 can be provided with an external label 522 indicating the contents batch number and/or information required by the FDA and or a pharmacy. External label 522 is, in some embodiments, provided on the end 524 of external packaging 520, as shown. End-labeling the packages means that the packages can be stacked efficiently on pharmacy shelves while permitting easy location of a package suitable for a particular patient. The end 524 of external packaging 520 is smaller in area than the sides of external packaging 520, thus allowing a greater number of labels to be exposed in a stack of packaging.

Tray Support

FIGS. 6A-6C illustrate an alternative packaging system for supporting a plurality of pneumostoma management systems 400. FIG. 6A shows a plan view of a support 610. FIG. 6B shows a perspective view of support 610, as assembled. FIG. 6C shows a kit 600 including 10 pneumostoma management systems 400 and packaging system 600.

FIG. 6A shows a plan view of a support 610. As shown in FIG. 6A, support 610 is, in some embodiments, created from a single sheet 612 of medical grade card. The pattern shown in FIG. 6A is preferably stamped in one go from card stock. As shown in FIG. 6A, the pattern delineates four side panels 612 a, 612 b, 612 c, 612 d; two end panels 614 a, 614 b; and five flaps 616 a, 616 b, 616 c, 616 d, 616 e. To facilitate folding and assembly, the card is, in some embodiments, scored along the dashed lines illustrated.

A plurality of holes 620 are punched in the side panels 612 a, 612 b, 612 c, 612 d. Each hole 620 comprises a central aperture 622 and a plurality of radiating slots 624. The holes 620 are sized slightly smaller than the tubular extension 416 of the sterile pneumostoma management system 400. The slots 624 allow the card surrounding the aperture 622 to bend and conform to the tubular extension 416 of the sterile pneumostoma management system 400.

A plurality of slots 630 are punched in the side panels 612 a, 612 b, 612 c, 612 d and end panels 614 a, 614 b. Each slot 630 defines a tab 632. The tabs 632 are designed to space support 610 from external packaging as illustrated in FIGS. 6B, 6C.

During assembly, an adhesive (not shown) is applied to the surface of flap 616 a which is then bonded to side panel 612 d to create a substantially square-sectioned tube having an interior volume. Flaps 616 b, 616 c, 616 d, 616 e are then folded over the ends of the square-sectioned tube. Finally, end panels 614 a, 614 b are folded over flaps 616 b, 616 c, 616 d, 616 e. Ends 615 a, 615 b are inserted into the interior volume to secure end panels 614 a, 614 b in place.

FIG. 6B shows a perspective view of support 610, as assembled. As shown in FIG. 6B, side panels 612 a, 612 b, 612 c, 612 d and end panels 614 a, 614 b form the surfaces of a rectangular cuboid enclosing an interior volume. Four tabs 632 project adjacent each of end panels 614 a, 614 b to serve as spacers. Ten apertures 620 pass through side panels 612 a, 612 b, 612 c, 612 d into the interior volume of the rectangular cuboid.

FIG. 6C shows a kit 600 which includes a plurality of pneumostoma management systems 400 assembled with support 610 and external packaging 640. As shown in FIG. 6C, the tubular extension of each tray 410 is placed through a hole 620 into the interior volume of the support 610. As most clearly shown in FIG. 6A, the holes are arranged such that the tubular extensions 416 are displaced from one another in the interior of support 610. The trays 410 are pushed against the side panels 612 a, 612 b, 612 c, 612 d. The trays 410 can overlap one another as shown. The tabs 632 project slightly beyond the trays 410. A total of ten pneumostoma management systems 400 can be assembled on support 610. The combination of support 610 and pneumostoma management system 400 is then inserted into external packaging 640 in the form of a box made of medical grade cardboard. Tabs 632 serve to space support 610 from the sides of external packaging 640 to allow room for trays 410.

Kit 600 provides pneumostoma management supplies sufficient for ten days of at-home pneumostoma care in volume-efficient packaging. With this configuration, for example, ten pneumostoma management devices 400 are supplied in a total package volume of approximately 6 liters or 0.6 liters per unit. This is a considerable savings in packaging volume compared to single trays.

FIG. 7 illustrates an alternative kit 700 which includes a support 710 and a plurality of pneumostoma management systems 400. As shown in FIG. 7, kit 700 can include up to 32 pneumostoma management systems 400 packaged with a support 710 and external packaging 780. Support 710 is, in some embodiments, created from a single block 712 of a lightweight material such as a foam or expanded plastic. A grid of apertures 720 is formed into opposite sides of the block 712. The apertures 720 are offset from one another so that the apertures on opposite sides of support 710 do not interfere with one another. The size of the block 712 and the number of apertures 720 is selected to allow support 710 to receive a desired number of sterile trays 410. Kit 700 can be configured, for example, to support 7, 14, 28 or more pneumostoma management systems

The tubular extension of each tray 400 of pneumostoma management systems 400 is placed through an aperture 720 into the interior volume of the support 710. A total of 16 pneumostoma management systems 400 can be received into the apertures 420 on each side of support 710. The assembly of pneumostoma management devices 400 and support 710 is designed to be placed inside external packaging 780. External packaging 780 is a box made of medical-grade card and only slightly larger in internal dimensions that the maximum external dimensions of the assembly of pneumostoma management devices 400 and support 710. In the configuration of FIG. 7, for example, pneumostoma management devices 400 can be supplied in a total package volume of approximately 16 liters or 0.5 liters per unit. This is a considerable savings in packaging volume compared to single trays. Additional volume savings can be achieved by overlapping the trays somewhat.

FIGS. 8A-8B shows an alternative support 810. Support 810 is designed to support a single pneumostoma management system 400. Support 810 is in the form of a wedge 812 with each wedge including an aperture 820. Wedge 812, can be made out of a lightweight material such as a foam or expanded plastic. Aperture 820 is connected to one side of wedge 812 by a slot 814. The tubular extension 416 of a pneumostoma management system 400 is placed through aperture 820 into the interior volume of wedge 812. Alternatively, the tubular extension 416 of a pneumostoma management system 400 is placed through slot 814 into the interior volume of wedge 812.

As shown in FIG. 8B, wedge 812 is designed so that a plurality of wedges 812 can be stacked to form a rectangular cuboid configuration with a plurality of pneumostoma management systems 400 entering from opposing sides. The configuration avoids interference of the tubular extensions of the pneumostoma management systems. As shown in FIG. 8B, fourteen pneumostoma management systems are provided as part of kit 800 which can be placed in external packaging box 880. The plurality of foam supports 810 and pneumostoma management systems 400 may then be inserted into external packaging 880. Again, with this configuration, for example, fourteen pneumostoma management devices 400 can be supplied in a total package volume of approximately 7 liters or 0.5 liters per unit. This is a considerable savings in packaging volume compared to single trays. Additional volume savings can be achieved by overlapping the trays somewhat.

Materials

In preferred embodiments the pneumostoma management device and tray are formed from biocompatible polymers. In general, preferred materials for manufacturing pneumostoma management devices and trays are biocompatible thermoplastic elastomers that are readily utilized in injection molding and extrusion processing. As will be appreciated, other suitable similarly biocompatible thermoplastic or thermoplastic polymer materials can be used without departing from the scope of the invention.

Biocompatible polymers for manufacturing pneumostoma management devices and trays may be selected from the group consisting of polyethylenes (HDPE), polyvinyl chloride, polyacrylates (polyethyl acrylate and polymethyl acrylate, polymethyl methacrylate, polymethylcoethyl acrylate, ethylene/ethyl acrylate), polycarbonate urethane (BIONATEG), polysiloxanes (silicones), polytetrafluoroethylene (PTFE, GORE-TEX®, ethylene/chlorotrifluoroethylene copolymer, aliphatic polyesters, ethylene/ tetrafluoroethylene copolymer), polyketones (polyaryletheretherketone, polyetheretherketone, polyetherether-ketoneketone, polyetherketoneetherketoneketone polyetherketone), polyether block amides (PEBAX, PEBA), polyamides (polyamideimide, PA-11, PA-12, PA-46, PA-66), polyetherimide, polyether sulfone, poly(iso)butylene, polyvinyl chloride, polyvinyl fluoride, polyvinyl alcohol, polyurethane, polybutylene terephthalate, polyphosphazenes, nylon, polypropylene, polybutester, nylon and polyester, polymer foams (from carbonates, styrene, for example) as well as the copolymers and blends of the classes listed and/or the class of thermoplastics and elastomers/thermoplastic elastomers in general. In one preferred embodiment, the tube is made of Pebax® a block copolymer with suitable mechanical and chemical properties available from Arkema (Colombes, France). Another suitable material is C-FLEX® thermoplastic elastomer available as extruded tube in a variety of dimensions and durometers from Saint-Gobain Performance Plastics in Clearwater, Fla. Reference to appropriate polymers that can be used for manufacturing pneumostoma management devices and trays can be found, for example, in the following documents: PCT Publication WO 02/02158, entitled “Bio-Compatible Polymeric Materials;” PCT Publication WO 02/00275, entitled “Bio-Compatible Polymeric Materials;” and, PCT Publication WO 02/00270, entitled “Bio-Compatible Polymeric Materials” all of which are incorporated herein by reference.

The foregoing description of preferred embodiments of the present invention has been provided for the purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many embodiments were chosen and described in order to best explain the principles of the invention and its practical application, thereby enabling others skilled in the art to understand the invention for various embodiments and with various modifications that are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the claims and their equivalents. 

1. A packaging system adapted for storing multiple medical disposable devices in a volumetric efficient manner comprising: a plurality of trays connected together with each tray including a tray base with tubular extension extending about perpendicular and rearwardly from the tray base; and a tray cover that covers each of the plurality of trays.
 2. The system of claim 1 wherein a first dimension of the tray base, a second dimension of the tray base and a dimension of said tubular extension define about a cube.
 3. The system of claim 1 wherein said trays are releasably connected together.
 4. The system of claim 1 wherein said trays are one of formed together so as to be severed one tray from the other and connected together with at least another material.
 5. The system of claim 1 wherein the tubular extensions are all about parallel to each other.
 6. The system of claim 1 said tray cover is made of a gas permeable material.
 7. The system of claim 1 including: a second plurality of trays each with second tubular extensions; a third plurality of trays each with third tubular extensions; a fourth plurality of trays each with fourth tubular extensions; with the plurality of trays positioned about perpendicular to the second plurality of trays; with the second plurality of trays positioned about perpendicular to the third plurality of trays; with the third plurality of trays about perpendicular to the fourth plurality of trays; and with the fourth plurality of trays about perpendicular to the plurality of trays.
 8. The system of claim 7 wherein the tubular extensions are about parallel, second tubular extensions are about parallel, the third tubular extensions are about parallel, and said fourth tubular extensions are about parallel.
 9. The system of claim 7 wherein the tubular extensions are about perpendicular to the second tubular extensions, said second tubular extensions are about perpendicular to the third tubular extensions, the third tubular extensions are about perpendicular to the fourth tubular extensions, and the fourth tubular extensions are about perpendicular to the tubular extensions.
 10. The system of claim 7 wherein said tubular extensions and said third tubular extensions are about parallel, and the second tubular extensions and said fourth tubular extensions are about parallel.
 11. The system of claim 7 wherein the plurality of trays is displaced from the second plurality of trays by at least about a width of one of said second tubular extensions, said second plurality of trays is displaced from the third plurality of trays by at least a width of one of said third tubular extensions, and said four plurality of trays is displaced from the plurality of trays by at least a width of one of said fourth tubular extensions.
 12. The system of claim 7 wherein said second plurality of trays is off-set from the plurality of trays, said third plurality of trays is off-set from said second plurality of trays, said fourth plurality of trays is off-set from said third plurality of trays, and said plurality of trays is off-set from the fourth plurality of trays.
 13. The system of claim 1 including: a second plurality of trays each with second tubular extensions; and with the plurality of trays positioned about parallel to the second plurality of trays.
 14. The system of claim 13 wherein the tubular extensions are about parallel, and second tubular extensions are about parallel.
 15. The system of claim 13 wherein the plurality of trays is displaced from the second plurality of trays by at least about a width of one of said second tubular extensions.
 16. The system of claim 13 wherein said second plurality of trays is off-set from the plurality of trays
 17. The system of claim 1 wherein said plurality of trays is connected together with an internal structure.
 18. The system of claim 1 wherein said plurality of trays is connected together with a solid internal structure.
 19. The system of claim 1 wherein said plurality of trays is connected together with a hollow structure.
 20. The system of claim 1 wherein said plurality of trays is connected together with a light weight material including at least one of a foam or an expanded plastic.
 21. The system of claim 1 wherein said plurality of trays is connected with a structure with a plurality of ports that receive said tubular extensions.
 22. The system of claim 1 wherein each tubular extension is held in a wedge shape structure.
 23. The system of claim 13 wherein each said tubular extensions is held in a wedge shaped structure, and each of said second tubular extensions is held in a second wedge shaped structure with each wedge shaped structure positioned adjacent each second wedge shaped structure.
 24. The system of claim 23 wherein one of the wedge shaped structure positioned adjacent to one of the second wedge shaped structures together form about a cube shape.
 25. The system of claim 7 wherein said plurality of trays, said second plurality of trays, said third plurality of trays and said fourth plurality of trays are all connected together by at least one of an internal structure, a solid internal structure, a hollow structure, a light weight material including at least one of foam and an expanded plastic, a structure with a plurality of ports that receive said tubular extensions, and a housing that contains a plurality of wedge shaped structure that can receive said tubular extensions.
 26. The system of claim 13 wherein said plurality of trays, and said second plurality of trays, are all connected together by at least one of an internal structure, a solid internal structure, a hollow structure, a light weight material including at least one of foam and an expanded plastic, a structure with a plurality of ports that receive said tubular extensions, and a housing that contains a plurality of wedge shaped structure that can receive said tubular extensions.
 27. The system of claim 1 wherein each tray occupies a total volume of about less than 0.6 liters
 28. The system of claim 1 wherein each tray occupies a total volume of about less than 0.5 liters.
 29. The system of claim 1 wherein said trays are arranged in a treatment sequence.
 30. The system of claim 1 wherein at least some of the trays are adapted to contain different devices.
 31. The system of claim 1 wherein at least some of the trays are adapted to contain at least one of auxiliary supplies, maintenance supplies, assessment supplies, diagnostic supplies, and treatment supplies.
 32. The system of claim 1 containing one of seven trays, fourteen trays, and twenty eight trays.
 33. The system of claim 1 wherein said tray covers are independent from each other.
 34. The system of claim 1 wherein said plurality of trays are connected in-line.
 35. The system of claim 1 wherein said tray base has as least one linear dimension that is about equivalent to a length of said tubular extension.
 36. A packaging system adapted for storing multiple medical disposable devices in a volumetric efficient manner comprising: a plurality of trays connected together with each tray including a tray base with tubular extension extending about perpendicular and rearwardly from the tray base; a tray cover that covers each of the plurality of trays. a second plurality of trays each with second tubular extensions; a third plurality of trays each with third tubular extensions; a fourth plurality of trays each with fourth tubular extensions; with the plurality of trays positioned about perpendicular to the second plurality of trays; with the second plurality of trays positioned about perpendicular to the third plurality of trays; with the third plurality of trays about perpendicular to the fourth plurality of trays; and with the fourth plurality of trays about perpendicular to the plurality of trays; and wherein said second plurality of trays is off-set from the plurality of trays, said third plurality of trays is off-set from said second plurality of trays, said fourth plurality of trays is off-set from said third plurality of trays, and said plurality of trays is off-set from the fourth plurality of trays; and wherein said plurality of trays, said second plurality of trays, said third plurality of trays and said fourth plurality of trays are all connected together by at least one of an internal structure, a solid internal structure, a hollow structure, a light weight material including at least one of foam and an expanded plastic, a structure with a plurality of ports that receive said tubular extensions, and a housing that contains a plurality of wedge shaped structure that can receive said tubular extensions.
 37. A packaging system adapted to store multiple medical disposable devices in a volumetric efficient manner comprising: a plurality of planar covers connected together, with each planar cover including a tubular cover extending about perpendicular and rearwardly from each of the planar cover; a second plurality of planar covers, each with a second tubular cover extending from each said second planar cover; a third plurality of planar covers, each with a third tubular cover extending from each said third planar cover; a fourth plurality of planar covers, each with a fourth tubular cover extending from each said fourth planar cover; and with the plurality of planar covers is about perpendicular to the second plurality of planar covers and the second plurality of planar covers is about perpendicular to the third plurality of planar covers and said third plurality of planar covers is about perpendicular to the fourth plurality of planar covers; and wherein said plurality of planar covers, said second plurality of planar covers, said third plurality of planar covers and said fourth plurality of planar covers are all connected together by at least one of an internal structure, a solid internal structure, a hollow structure, a light weight material including at least one of foam and an expanded plastic, a structure with a plurality of ports that receive said tubular covers, and a housing that contains a plurality of wedge shaped structure that can receive said tubular covers.
 38. The system of claim 37 in combination with multiple medical disposable devices wherein each disposable devices includes an adhesive cover and a vent extending about perpendicular from said adhesive cover. 